Monthly update of U.S. Food and Drug Administration (FDA) approvals impacting the workers' compensation industry. myMatrixx's report includes new drug and indication approvals, discontinuation and withdrawals, new dosages or formulations of existing products and newly available generics in the last 12 months.
Monthly Drug News
A generic version of Horizon Pharma’s Pennsaid® 2% (diclofenac sodium topical solution) is now available. Other topical products containing diclofenac are already available as generics, but Apotex Inc. is the first with the 2% solution.
Impact to Workers’ Comp
Topical diclofenac is a popular product in workers’ compensation, whether it is the 1% gel, 1.3% patch or solution (either 1.5% or 2%). In retail settings, Pennsaid 2% tends to be the most costly formulation, so its generic availability is a welcome addition.
For any questions about the use of Pennsaid, diclofenac, or other topical NSAIDs and potential relatedness to a claim, please consult with your myMatrixx pharmacist.
New Brand Drug Pipeline
| Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
|---|---|---|---|
| Nalmefene Injection | Opioid Agonist | Opioid Overdose | Anticipated summer 2022. Approved February 8, 2022. |
|
Baclofen Granules (Lyvispah™) |
Muscle Relaxant | Muscle Spasms | Launch pending. Approved November 22, 2021. |
| Buprenorphine Depot Injection (Brixadi™) | Opioid Agonist | Treatment of Opioid Addiction |
FDA review pending. |
| Oxycodone (Aximris XR™) | Opioid Analgesic – Extended Release |
Pain | FDA review pending. |
|
Meloxicam/Rizatriptan |
NSAID/Serotonin Agonist |
Migraine Headache | FDA review pending. |
Generic Pipeline
| Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
|---|---|---|---|
| Vilazodone (Viibryd®) | Antidepressant | Depression | Patent set to expire June 2022. |
| Dabigatran (Pradaxa®) | Anticoagulant | Treatment/Prophylaxis of Deep Vein Thrombosis | First patent set to expire December 2021. Generic anticipated June 2022. |
| Oxycodone HCl (Oxaydo®) | Opioid Agonist | Pain | Generic exclusivity anticipated in 2022. |
| Apixaban (Eliquis®) | Anticoagulant | Treatment/Prophylaxis of Deep Vein Thrombosis | Generics approved December 23, 2019, but settlements expected to delay launch for at least a few years. |
Available in the Last 12 Months
| Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
|---|---|---|---|
| Naloxone Injection (Zimhi™) | Opioid Antagonist | Opioid Overdose | March 2022 |
| Celecoxib/Tramadol (Seglentis®) | NSAID/Opioid Agonist | Pain | March 2022 |
| Baclofen Oral Suspension (Fleqsuvy™) | Muscle Relaxant | Muscle Spasms | March 2022 |
| Celecoxib Oral Liquid (Elyxyb™) | NSAID | Migraine Headache Treatment | February 2022 |
| Naloxone Nasal Spray (Kloxxado™) | Opioid Antagonist | Opioid Overdose | August 2021 |
Newly Available Generics
| Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
|---|---|---|---|
| Diclofenac Sodium 2% (Pennsaid®) Solution | Topical NSAID | Pain | May 2022 |
|
Diclofenac Potassium (Zipsor®) Capsule |
NSAID | Pain | March 2022 |
| Naloxone HCl (Narcan®) Nasal Spray | Opioid Antagonist | Opioid Overdose | December 2021 |
| Zolmitriptan Nasal Spray (Zomig®) | Serotonin Agonist | Migraine Headache Treatment | November 2021 |
| Nebivolol (Bystolic®) | Beta Blocker | Beta Blocker | September 2021 |
| Ibuprofen/Famotidine (Duexis®) | NSAID/H-2 Receptor Antagonist | Pain/Inflammation | August 2021 |
Discontinuations & Withdrawals
| Medication (Brand name) | Drug Class | Therapeutic Use | Status Update |
|---|---|---|---|
| Hydrocodone ER Capsules (Zohydro® ER) | Opioid Agonist | Pain | Manufacturer has stopped distribution and FDA has rescinded approval effective February 2022. |